Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast that is potentially curable
• T0-4 (dermal involvement on pathology assessment only), N0-2, M0
• No clinical T4 disease
• Previously treated with one of the following:
• Total mastectomy and level II axillary node dissection
• Partial mastectomy and level II axillary node dissection with planned breast radiotherapy after completion of adjuvant chemotherapy regimen*
• Patients with a positive sentinel node biopsy must undergo level II axillary node dissection or sufficient nodal sampling
• If microscopic residual in situ or invasive disease is present at total or partial mastectomy margins, planned radiotherapy must also include a boost to the tumor bed
• No residual tumor in the axilla after dissection
• Axillary node positive
• Negative nodes allowed if the tumor is ≥ 1 cm and 1 or more of the following criteria defining high-risk node-negative disease are met:
• Histological grade III or,
• Estrogen receptor negative or,
• Lymphatic/vascular invasion
• Hormone receptor status:
• Estrogen receptor status known

PATIENT CHARACTERISTICS:

Age:

• 60 and under

Sex:

• Female

Menopausal status:

• Pre- or postmenopausal

Performance status:

• ECOG 0-2

Life expectancy:

• At least 5 years

Hematopoietic:

• WBC ≥ 3,000/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic:

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

Renal:

• Creatinine ≤ 1.5 times ULN

Cardiovascular:

• LVEF ≥ limit of normal by MUGA or echocardiogram
• No arrhythmia requiring ongoing treatment
• No congestive heart failure
• No documented coronary artery disease

Other:

• No other malignancy except:
• Adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• Ductal or lobular carcinoma in situ that has been curatively treated by surgery alone
• Other prior malignancies (except breast cancer) curatively treated more than 5 years prior to study entry
• No serious underlying medical illness or psychiatric or addictive disorder that would preclude study compliance
• No known hypersensitivity to E. coli-derived products, mammalian-cell derived products, or any study agents
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective non-hormonal contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy for breast cancer
• No concurrent pegfilgrastim or darbepoetin alfa (Arm II)
• Allowed on arms 1 and 3 if medically necessary

Chemotherapy:

• No prior chemotherapy for breast cancer

Endocrine therapy:

• No prior hormonal therapy for breast cancer
• No concurrent hormone replacement therapy
• No concurrent selective estrogen-receptor modulators (e.g., raloxifene for the treatment or prevention of osteoporosis)
• No concurrent oral contraceptives (i.e., birth control pills)
• No other concurrent aromatase inhibitors

Radiotherapy:

• See Disease Characteristics
• No prior radiotherapy for breast cancer

Surgery:

• See Disease Characteristics
• No more than 12 weeks since prior total or partial mastectomy (including re-excision of margins)

Other:

• At least 30 days since prior investigational drugs
• No other concurrent investigational drugs
• Concurrent bisphosphonates for the treatment or prevention of osteoporosis allowed